Loteprednol Etabonate
Loteprednol Etabonate Ophthalmic Suspension, 0.5%
Approved
Approval ID
66977c58-1e0c-4add-8ff1-c90050dbcd10
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2022
Manufacturers
FDA
Akorn
DUNS: 117696873
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Loteprednol Etabonate
PRODUCT DETAILS
NDC Product Code50383-265
Application NumberANDA207609
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateMarch 15, 2022
Generic NameLoteprednol Etabonate
INGREDIENTS (9)
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
LOTEPREDNOL ETABONATEActive
Quantity: 5 mg in 1 mL
Code: YEH1EZ96K6
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT